EP2008087B1 - Laminated biosensor manufacturing method - Google Patents
Laminated biosensor manufacturing method Download PDFInfo
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- EP2008087B1 EP2008087B1 EP07760264.7A EP07760264A EP2008087B1 EP 2008087 B1 EP2008087 B1 EP 2008087B1 EP 07760264 A EP07760264 A EP 07760264A EP 2008087 B1 EP2008087 B1 EP 2008087B1
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- European Patent Office
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- laser
- electrode
- diffusion barrier
- test strip
- processing technique
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/28—Electrolytic cell components
- G01N27/30—Electrodes, e.g. test electrodes; Half-cells
- G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
- G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
- G01N27/3272—Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels
Definitions
- the present invention relates to a method for manufacturing biosensors.
- a number of available systems allow people to conveniently monitor their blood glucose levels.
- Such systems typically include a disposable test strip to which the user applies a blood sample, and a meter that determines the blood glucose level.
- the test strip typically includes electrodes and a sample chamber that contains chemical constituents, such as a glucose enzyme and an electron mediator.
- chemical constituents such as a glucose enzyme and an electron mediator.
- the instrument applies a voltage to the electrodes to cause a redox reaction.
- the meter initiates one or more current measurements and calculates the glucose level based on at least one of the current measurements.
- WO 2005/066616 A2 describes a biosensor and method of making cross-reference to related applications, wherein electrode elements are provided having smooth, high quality edges that define gaps between electrodes, electrode traces and contact pads.
- US Patent Application Publication US 2004/0182703 A1 describes a system and methods for blood glucose sensing with an auto-on conductor for a wake up function and fill-detect electrodes for determining a mixing of the sample with the reagent layer.
- European Patent Application EP 1 195 441 A1 describes a biosensor that comprises a plate element with a pre-determined reaction zone and a recess positioned adjacent to the reaction zone.
- the biosensor also comprises a reagent that is positioned on at least a portion of the reaction zone.
- a reagent that is positioned on at least a portion of the reaction zone.
- Another method is described in U.S. Patent 6,875,327 .
- Miyazaki et al. describe a biosensor manufacturing process whereby a conductive layer is formed on a support. Electrodes are formed using a laser to form multiple "slits" in the conductive layer, electrically separating the working, counter and detecting electrodes. Following electrode formation, chemical reagents are selectively applied to the conductive layer.
- the manufacturing process can be improved. Specifically, the manufacturing process can be inefficient, time consuming, or unsuitable to form one or more biosensors described in the present disclosure.
- the present disclosure is directed to a manufacturing method designed to overcome one or more of the limitations in the prior art.
- the present invention is directed to a method of manufacturing a plurality of biosensor test strips for blood analysis as defined by the claims.
- a biosensor design, manufacturing method and method for measuring a fluid constituent is described.
- Many industries have a commercial need to monitor the concentration of particular constituents in a fluid.
- Oil refining, winemaking, and dairy are examples of industries where fluid testing is routine.
- people such as diabetics, for example, have a need to monitor a particular constituent within their bodily fluids using a biosensor.
- a number of systems are available that allow people to test a body fluid, such as, blood, urine, or saliva, to conveniently monitor the level of a particular fluid constituent, such as, for example, cholesterol, proteins, and glucose.
- a biosensor that may be obtained by the method of the invention may include a test strip, which can be disposable, that may facilitate the detection of a particular constituent of a fluid.
- the test strip can include a proximal end, a distal end and at least one electrode.
- the proximal end of the test strip may include a sample chamber for receiving a fluid to be tested.
- the sample chamber can be dimensioned and arranged to draw-in and hold a blood sample in the sample chamber to contact the electrodes by capillary action.
- the distal end of the test strip may be configured to operatively connect the test strip to a meter that may determine the concentration of the fluid constituent.
- the test strip can have, near its distal end, a plurality of electrical contacts that provide operative connection between the electrodes and the meter.
- the ends of the test strip can further include improved visual and/or tactile distinguishable section, such as, for example, a taper, in order to make it easier for the user to operatively connect the test strip to the
- the at least one electrode may include a working electrode, a counter electrode, and a fill-detect electrode.
- a diffusion barrier can be disposed between any adjacent electrodes, such as, for example, the working electrode and counter electrode.
- a reagent layer can be disposed in the sample chamber and may cover at least a portion of the working electrode, which can also be disposed at least partially in the sample chamber.
- the reagent layer can include, for example, an enzyme, such as glucose oxidase or glucose dehydrogenase, and a mediator, such as potassium ferricyanide or ruthenium hexamine, to facilitate the detection of glucose in blood. It is contemplated that other reagents and/or other mediators can be used to facilitate detection of glucose and other constituents in blood and other fluids.
- FIGS. 1A and 2 show a test strip 10, in accordance with an illustrative example of a biosensor obtained by the method of the present invention.
- Test strip 10 can take the form of a substantially flat strip that extends from a proximal end 12 to a distal end 14.
- the proximal end 12 of test strip 10 can be narrower than distal end 14 to provide facile visual recognition of distal end 14.
- test strip 10 can include a tapered section 16, in which the full width of test strip 10 tapers down to proximal end 12, making proximal end 12 narrower than distal end 14.
- a blood sample is applied to an opening in proximal end 12 of test strip 10
- providing tapered section 16 and making proximal end 12 narrower than distal end 14 can, in certain examples, assist the user in locating the opening where the blood sample is to be applied.
- other visual means such as indicia, notches, contours, textures, or the like can be used.
- Test strip 10 is depicted in FIGS. 1A and 2 as including a plurality of conductive components, such as, for example, electrodes.
- a conductive component can include any structure configured to at least partially conduct an electrical signal.
- a conductive component can extend substantially along the length of test strip 10 to provide an electrical contact near distal end 14 and a conductive region electrically connecting the region of the electrode near proximal end 12 to the electrical contact.
- the plurality of electrodes includes a working electrode 22, a counter electrode 24, a fill-detect anode 28, and a fill-detect cathode 30.
- the electrical contacts can include a working electrode contact 32, a counter electrode contact 34, a fill-detect anode contact 36, and a fill-detect cathode contact 38 positioned at distal end 14.
- the conductive regions can include a working electrode conductive region 40, electrically connecting the proximal end of working electrode 22 to working electrode contact 32, a counter electrode conductive region 42, electrically connecting the proximal end of counter electrode 24 to counter electrode contact 34, a fill-detect anode conductive region 44 electrically connecting the proximal end of fill-detect anode 28 to fill-detect contact 36, and a fill-detect cathode conductive region 46 electrically connecting the proximal end of fill-detect cathode 30 to fill-detect cathode contact 38.
- FIGS. 1A and 2 depict test strip 10 as including slot 52, forming a portion of a sample chamber 88 at proximal end 12.
- Slot 52 can define an exposed portion 54 of working electrode 22, an exposed portion 56 of counter electrode 24, an exposed portion 60 of fill-detect anode 28, and an exposed portion 62 of fill-detect cathode 30.
- the illustrative example is depicted including an optional auto-on conductor 48 disposed near distal end 14 to allow the meter to determine that a test strip is operatively connected to the meter.
- FIG. 1B is a top plan view of test strip 110 according to another illustrative example of a biosensor obtained by the method of the invention.
- test strip 110 includes a different electrode configuration, and a plurality of encoded electrical contacts 148 disposed near a distal end 114.
- Test strip 110 can take the form of a substantially flat strip that extends from a proximal end 112 to distal end 114, wherein the proximal end 112 of test strip 110 can be narrower than distal end 114 to provide facile visual recognition of distal end 14.
- test strip 110 can include a tapered section 116.
- Test strip 110 depicted in FIG. 1B can include a plurality of electrodes, such as, for example, a working electrode 122, a counter electrode 124, and fill-detect electrodes 128, 130.
- the electrical contacts can include a working electrode contact 132, a counter electrode contact 134, and fill-detect electrode contacts 136, 138 positioned at distal end 114.
- the conductive regions can include a working electrode conductive region 140, electrically connecting the proximal end of working electrode 122 to working electrode contact 132, a counter electrode conductive region 142, electrically connecting the proximal end of counter electrode 124 to counter electrode contact 134, and fill-detect conductive regions 144, 146 electrically connecting fill-detect electrodes 128, 130 to fill-detect contacts 136, 138.
- Test strip 110 can also include a slot 152 configured to receive a fluid sample.
- test strip 110 can include one or more diffusion barriers (not shown), as described below.
- test strip 110 can include one or more encoded electrical contacts 148 configured to encode a readable code, wherein the readable code can include test strip information, calibration information, or any other suitable data.
- encoded electrical contacts 148 can be resistant to scratching or abrasion.
- test strip 110 can include encoded electrical contacts 148 formed of two or more layers of conductive and/or semi-conductive material (not shown). Further information relating to encoded electrical contacts 49 encoding and abrasion resistance are described in co-owned U.S. Patent Application No. 11/458,298 .
- FIG. 3 shows a top plan view of a test strip according to an illustrative example.
- a diffusion barrier 47 may be formed between working electrode 22 and fill-detect anode 28 and fill-detect cathode 30. Diffusion barrier 47 can electrically separate exposed portion 54 of working electrode 22 and exposed portion 60 of fill-detect anode 28 and exposed portion 62 of fill-detect cathode 30.
- test strip 10 may also include a diffusion barrier 49 formed between working electrode 22 and counter electrode 24. Diffusion barrier 49 can electrically separate exposed portion 54 of working electrode 22 and exposed portion 56 of counter electrode 24.
- test strip 10 may include one or more diffusion barriers positioned between any adjacent electrodes.
- Diffusion barriers may be configured to improve the accuracy of determining constituent concentration by reducing the migration of electrochemically active components. For example, oxidized or reduced species formed by a redox reaction in the detection of glucose may migrate between working electrode 22 and counter electrode 24. This migration may generate spurious current, reducing the accuracy of constituent concentration determination.
- the width of diffusion barrier 49 may provide sufficient distance to reduce the effects of migration of electrochemically active components between exposed portion 54 of working electrode 22 and exposed portion 56 of counter electrode 24.
- the diffusion coefficient is ⁇ 7.6 ⁇ 10 -6 cm 2 /sec for potassium ferricyanide and ⁇ 8.8 ⁇ 10 -6 cm 2 /sec for ruthenium hexamine.
- charged potassium ferricyanide may migrate 87 micro-meters and charged ruthenium hexamine may migrate 93 micro-meters.
- the current caused by migrating charged components may be reduced by separating working electrode 22 and counter electrode 24 by a distance approximately equal to or greater than the diffusion distance, such as, for example, approximately 100 micro-meters for a biosensor using potassium ferricyanide or ruthenium hexamine.
- diffusion barrier 49 may separate working electrode 22 and counter electrode 24 by at least approximately 100 micro-meters.
- the diffusion distance for a given mediator is dependent upon the reaction time. For example, shorter reaction times decrease the diffusion distance. Subsequently, the width of diffusion barrier can be decreased. Longer reaction times increase diffusion distance, and subsequently, the width of diffusion barrier can increase. It is also contemplated that the diffusion distance may vary depending upon other factors related to the design and/or function of test strip 10, such as, for example, geometry, surface energy, and environmental factors.
- test strip 10 can have a generally layered construction.
- test strip 10 can include a base layer 18 that can substantially extend along the entire length or define the length of test strip 10.
- Base layer 18 can be formed from an electrically insulating material and can have a thickness sufficient to provide structural support to test strip 10.
- a conductive layer 20 may be disposed on at least a portion of base layer 18.
- Conductive layer 20 can comprise a plurality of electrodes.
- the plurality of electrodes includes a working electrode 22, a counter electrode 24, a fill-detect anode 28, and a fill-detect cathode 30.
- conductive layer 20 including an auto-on conductor 48 disposed on base layer 18 near distal end 14.
- diffusion barrier 49 may be a non-conductive region formed in conductive layer 20. It is contemplated that diffusion barrier 49 may be formed by at least partially ablating conductive layer 20 between working electrode 22 and counter electrode 24.
- Dielectric spacer layer 64 disposed on conductive layer 20.
- Dielectric spacer layer 64 may be composed of an electrically insulating material, such as polyester.
- Dielectric spacer layer 64 can cover portions of working electrode 22, counter electrode 24, fill-detect anode 28, fill-detect cathode 30, and conductive regions 40-46, but in the illustrative example of FIG. 2 does not cover electrical contacts 32-38, and/or auto-on conductor 48.
- dielectric spacer layer 64 can cover a substantial portion of conductive layer 20 thereon, from a line proximal of contacts 32 and 34 to proximal end 12, except for slot 52 extending from proximal end 12.
- a cover 72 having a proximal end 74 and a distal end 76, is shown in FIG. 2 as being disposed at proximal end 12 and configured to cover slot 52 and partially form sample chamber 88.
- Cover 72 can be attached to dielectric spacer layer 64 via an adhesive layer 78.
- Adhesive layer 78 can include a polyacrylic or other adhesive and can consist of sections disposed on cover 72 on opposite sides of slot 52.
- a break 84 in adhesive layer 78 extends from distal end 70 of slot 52 to an opening 86.
- Cover 72 can be disposed on spacer layer 64 such that proximal end 74 of cover 72 may be aligned with proximal end 12 and distal end 76 of cover 72 may be aligned with opening 86, thereby covering slot 52 and break 84. Further, cover 72 can be composed of an electrically insulating material, such as polyester. Cover 72 can also be transparent.
- Slot 52 can define sample chamber 88 in test strip 10 for receiving a fluid sample, such as a blood sample, for measurement in the illustrative example.
- a proximal end 68 of slot 52 can define a first opening in sample chamber 88, through which the fluid sample is introduced.
- break 84 can define a second opening in sample chamber 88, for venting sample chamber 88 as sample enters sample chamber 88.
- Slot 52 may be dimensioned such that a blood sample applied to its proximal end 68 is drawn into and held in sample chamber 88 by capillary action, with break 84 venting sample chamber 88 through opening 86, as the blood sample enters.
- cover 72 can include one or more holes, or vents (not shown), configured to permit fluid flow into chamber 88.
- slot 52 can be dimensioned so that the volume of blood sample that enters sample chamber 88 by capillary action is about 1 micro-liter or less.
- a reagent layer 90 may be disposed in sample chamber 88.
- reagent layer 90 contacts exposed portion 54 of working electrode 22. It is also contemplated that reagent layer 90 may or may not contact diffusion barrier 49 and/or exposed portion 56 of counter electrode 24.
- Reagent layer 90 may include chemical components to enable the level of glucose or other analyte in the fluid, such as a blood sample, to be determined electro-chemically.
- reagent layer 90 can include an enzyme specific for glucose, such as glucose dehydrogenase or glucose oxidase, and a mediator, such as potassium ferricyanide or ruthenium hexamine.
- Reagent layer 90 can also include other components, such as buffering materials (e.g., potassium phosphate), polymeric binders (e.g., hydroxypropyl-methyl-cellulose, sodium alginate, microcrystalline cellulose, polyethylene oxide, hydroxyethylcellulose, and/or polyvinyl alcohol), and surfactants (e.g., Triton X-100 or Surfynol 485).
- buffering materials e.g., potassium phosphate
- polymeric binders e.g., hydroxypropyl-methyl-cellulose, sodium alginate, microcrystalline cellulose, polyethylene oxide, hydroxyethylcellulose, and/or polyvinyl alcohol
- surfactants e.g., Triton X-100 or Surfynol 485.
- Chemical components of reagent layer 90 can react with glucose in the blood sample in the following way.
- the glucose oxidase initiates a reaction that oxidizes the glucose to gluconic acid and reduces the ferricyanide to ferrocyanide.
- an appropriate voltage is applied to working electrode 22, relative to counter electrode 24, the ferrocyanide is oxidized to ferricyanide, thereby generating a current that is related to the glucose concentration in the blood sample.
- diffusion barrier 49 may improve the accuracy of the determination by reducing the migration of one or more components of reagent layer 90.
- a component charged by oxidation or reduction such as, for example, ruthenium hexamine, may migrate between working electrode 22 and counter electrode 24.
- the migration or "shuttling" of the charged components may generate spurious current, reducing the accuracy of glucose concentration determination.
- the width of diffusion barrier 49 is designed to provide sufficient distance to limit the migration of charged constituents between exposed portion 54 of working electrode 22 and exposed portion 56 of counter electrode 24.
- the position and dimensions of the layers of illustrative test strip 10 can result in test strip 10 having regions of different thicknesses.
- the thickness of spacer layer 64 may constitute a substantial thickness of test strip 10.
- the distal end of spacer layer 64 may form a shoulder 92 in test strip 10.
- Shoulder 92 may delineate a thin section 94 of test strip 10 extending from shoulder 92 to distal end 14, and a thick section 96 of test strip 10 extending from shoulder 92 to proximal end 12.
- the elements of test strip 10 used to electrically connect it to the meter (not shown), namely, electrical contacts 32-38 and auto-on conductor 48, can all be located in thin section 94.
- the meter can be sized and configured to receive relatively thin section 94 but not relatively thick section 96. This may help the user to insert the correct end of test strip 10, i.e., distal end 14 of relatively thin section 94, and can prevent the user from inserting the wrong end, i.e., proximal end 12 of relatively thick section 96, into the meter.
- Test strip 10 can be sized for easy handling.
- test strip 10 can measure approximately 35 mm long (i.e., from proximal end 12 to distal end 14) and about 9 mm wide.
- base layer 18 can be a polyester material about 0.25 mm thick and dielectric spacer layer 64 can be about 0.094 mm thick and cover portions of working electrode 22.
- Adhesive layer 78 can include a polyacrylic or other adhesive and have a thickness of about 0.013 mm.
- Cover 72 can be composed of an electrically insulating material, such as polyester, and can have a thickness of about 0.095 mm.
- Sample chamber 88 can be dimensioned so that the volume of fluid sample is about 1 micro-liter or less.
- slot 52 can have a length (i.e., from proximal end 12 to distal end 70) of about 3.56 mm, a width of about 1.52 mm, and a height (which can be substantially defined by the thickness of dielectric spacer layer 64) of about 0.13 mm.
- the dimensions of test strip 10 for suitable use can be readily determined by one of ordinary skill in the art. For example, a meter with automated test strip handling may utilize a test strip smaller than 9 mm wide.
- FIGS. 1A , 1B and 2 show an illustrative example of test strip 10 obtained by the method of the invention
- other configurations, chemical components and electrode arrangements could be used.
- different arrangements of working electrode, counter electrode, and/or diffusion barriers can also be used.
- working electrode 22, counter electrode 24 and diffusion barriers 47, 49 are separated by boundaries generally aligned in the x-axis, perpendicular to the length of test strip 10 in the y-axis.
- working electrode 22, counter electrode 24 and diffusion barrier 49 can be separated by boundaries generally aligned in the y-axis, parallel to the length of test strip 10. It is also contemplated that working electrode 22, counter electrode 24 and/or diffusion barrier 49 may be aligned at any angle relative the length of test strip 10.
- FIGs. 4A , 4B , and 5 show one test strip structure partially fabricated in order to show various steps in an illustrative method for forming the test strip.
- the outer shape of the test strip that would be formed in the overall manufacturing process is shown as a dotted line.
- steps for manufacturing test strip 10 as shown in FIGs. 1A , 4B , and 2 , it is to be understood that similar steps can be used to manufacture test strips having other configurations of components.
- Test strips 10 can be manufactured by forming a plurality of test strips 10 in an array along a reel of substrate material.
- the illustrative manufacturing process employs base layer 18 covered by conductive layer 20.
- Conductive layer 20 and base layer 18 can be in the form of a reel, such as, for example, a ribbon, web, sheet, or other similar structure.
- Conductive layer 20 can comprise any suitable conductive or semi-conductor material, such as gold, silver, palladium, carbon, tin oxide and others known in the art.
- the conductive material can be any suitable thickness and can be bonded to base layer 18 by any suitable means.
- Conductive layer 20 can be formed by direct writing, sputtering, screen printing, contact printing or any suitable manufacturing method.
- One exemplary process is direct writing of electrodes as described in commonly-assigned, copending provisional patent application No. 60/716,120 "Biosensor with Direct Written Electrode,” filed September 13, 2005, the disclosure of which is hereby incorporated herein by reference in its entirety.
- Another exemplary process is screen printing as described in commonly-assigned, U.S. Patent No. 6,743,635 "System and methods for blood glucose sensing," filed Nov. 1, 2002, the disclosure of which is hereby incorporated herein by reference in its entirety.
- test strip 10, 110 may include a plurality of electric components, such as, for example, electrodes 22, 122, 24, 124, 28, 128 and 30, 130 disposed in conductive layer 20, 120 and substantially extending from proximal end 12, 112 to distal end 14, 114.
- the electric components of test strip 10, 110 may be partially formed by forming a trace 80, 180.
- trace 80 may be indicated by the solid lines on conductive layer 20 as shown in FIG. 4A .
- Trace 80, 180 may at least partially define one or more boundaries of one or more electric components of test strip 10, 110.
- the electric components of the test strip may be at least partially formed by one or more processing techniques.
- one or more boundaries of some electric components may be at least partially formed by any process used to form the conductive layer. It is contemplated that a processing technique is used to more precisely define the boundaries of some electric components by laser ablation.
- trace 80, 180 can be formed by laser ablation where laser ablation can include any device suitable for removal of the conductive layer in appropriate time and with appropriate precision and accuracy.
- laser ablation can include any device suitable for removal of the conductive layer in appropriate time and with appropriate precision and accuracy.
- Various types of lasers can be used for sensor fabrication, such as, for example, solid-state lasers (e.g. Nd:YAG and titanium sapphire), copper vapor lasers, diode lasers, carbon dioxide lasers and excimer lasers. Such lasers may be capable of generating a variety of wavelengths in the ultraviolet, visible and infrared regions.
- excimer laser provides wavelength of about 248 nm
- a fundamental Nd:YAG laser gives about 1064 nm
- a frequency tripled Nd:YAG wavelength is about 355 nm
- a Ti:sapphire laser is at approximately 800 nm.
- the power output of these lasers may vary and is usually in range about 10-100 watts.
- trace 80, 180 can be formed by laser ablation process in combination with other suitable processes known in the art.
- the laser ablation process includes a laser system.
- the laser system can include a laser source.
- the laser system can further include means to form trace 80, 180 such as, for example, a focused beam, projected mask or other suitable technique.
- the use of a focused laser beam can include a device capable of rapid and accurate controlled movement to move the focused laser beam relative to conductive layer 20, 120.
- a scanner such as HurryScan (ScanLabs) may be used to direct the laser beam in direct write applications.
- the use of a mask can involve a laser beam passing through the mask to selectively ablate specific regions of conductive layer 20, 120.
- a single mask can define trace 80, 180, or multiple masks may be required to form trace 80, 180.
- the laser system can move relative to conductive layer 20, 120.
- the laser system, conductive layer 20, 120, or both the laser system and conductive layer 20, 120 may move to allow formation of trace 80, 180 by laser ablation.
- Exemplary devices available for such ablation techniques include a laser system available from LasX Industries, White Bear Lake, Minnesota and laser micro machining systems from Exitech, Ltd. (Oxford, United Kingdom).
- trace 80, 180 may include one or more kerfs at least partially electrically isolating adjacent electric components of test strip 10, 110.
- a kerf may form a linear and/or curvilinear electrically-isolating region between adjacent electric components. It is also contemplated that a kerf may include a turn of any angle, such as, for example, an orthogonal angle whereby the kerf forms an "L" shape.
- a kerf of may partially electrically isolate adjacent electric components.
- a kerf may partially electrically isolate adjacent electric components as the electric components may remain electrically connected following kerf formation.
- counter electrode contact 34 and fill-detect cathode contact 38 may remain electrically connected following the formation of a kerf 57 partially separating the two electric components.
- Counter electrode contact 34 and fill-detect cathode contact 38 may subsequently be electrically isolated by a separation process as described below, whereby test strip 10 is separated from the laminate reel along the dashed line as shown in FIG. 4A .
- one or more laser ablation processing techniques may be used to form a trace.
- a first laser ablation processing technique may utilize a first laser beam of a first width and a second laser ablation processing technique may utilize a second laser beam of a second width, wherein the first and second widths may be different.
- the first laser beam may be used to form one or more boundaries of contiguous electric components and the second laser beam may be used to form one or more diffusion barriers, and/or other electric components.
- the width of the second laser beam may be at least as wide as the diffusion distance for the specific reagent used for test strip 10.
- a second laser beam ⁇ 100 micro-meters wide may be used to form diffusion barrier 49 by at least partially removing material from conductive layer 20 between working electrode 22 and counter electrode 24.
- a second laser beam ⁇ 100 micro-meters wide may be used to form one or more boundaries of encoding electrical contacts 148, while a first laser beam ⁇ 20 micro-meters wide may be used to form one or more boundaries of working electrode 122, counter electrode 124, and/or fill-detect electrodes 128, 130.
- a first laser ablation processing technique may utilize a first laser beam generated by a first type of laser and a second laser ablation processing technique may utilize a second laser beam generated by a second type of laser, wherein the first and second types of lasers are different.
- various types of lasers may be used to form various kerfs in the test strip.
- one kerf may be formed by a laser operating in the infrared spectrum while another kerf may be formed by a laser operating in the ultraviolet spectrum.
- a laser operating in the infrared spectrum could be used to form a kerf 101, while a laser operating in the ultraviolet spectrum could be used to form a kerf 103.
- kerf 101 can form a boundary of one or more conductive components at distal end 114, such as, for example, electrical contacts 132, 134, 136, 138, and/or 148.
- kerf 103 can form a boundary of one or more conductive components at proximal end 116, such as, for example, electrodes 122, 124, 128, and/or 130.
- a first laser ablation processing technique may utilize a first laser beam generated at a first power and a second laser ablation processing technique may utilize a second laser beam generated a second power, wherein the first and second laser powers may be different.
- one laser may have sufficient power to ablate material to a desired depth, while another laser may ablate material to a smaller or larger depth.
- one laser may be of sufficient power to penetrate one or more layers of material, while another laser may be able to penetrate fewer or greater layers of material.
- test strip 10, 110 can include electrical contacts formed of two or more layers of conductive and/or semi-conductive material, as described by U.S. Patent Application No. 11/458,298 .
- a first laser ablation process may be configured to ablate two or more layers of conductive and/or semi-conductive material to form kerf 101, while a second laser ablation process may be configured to ablate less material at a lower power to form kerf 103.
- a TR Fiber laser manufactured by SPI (Southampton, UK) operating at suitable power may be used to form kerf 101.
- SPI Southampton, UK
- Such a manufacturing technique can permit formation of conductive components at proximal end 116 at appropriate resolution for the required electrochemical process and formation of conductive components at distal end 114 requiring higher power ablation to penetrate of multilayered material.
- different laser ablation processes can be applied at different stages during a manufacturing process.
- kerf 101 may be formed following deposition of one or more layers of conductive and/or semi-conductive material while kerf 103 may be formed prior to such a deposition process. Therefore, different processing techniques, such as lasers operating at different powers, different beam width, being of different type, etc., can be used to form one or more boundaries of one or more conductive components.
- different processing techniques such as lasers operating at different powers, different beam width, being of different type, etc.
- an AVIA-X laser manufactured by Coherent can be used to form kerf 103 when operated at a first laser power, and kerf 101 when operated at a second laser power higher than the first laser power.
- diffusion barriers may be formed by a plurality of kerfs.
- diffusion barrier 49 may be at least partially formed by kerfs 51, 53 and 55, where kerfs 51 and 53 may be any width less than the width of diffusion barrier 49.
- the width and/or trajectory of the one or more kerfs used to form diffusion barrier 49 may be sufficient to form a region electrically isolating working electrode 22 and counter electrode 24.
- the distance between kerfs 51 and 53 can define the width of diffusion barrier 49 and thus the separation distance between working electrode 22 and counter electrode 24.
- Diffusion barrier 49 may be contiguous with at least one boundary of one or more electric components, such as, for example, working electrode 22 and counter electrode 24. As shown in FIG. 4A , boundaries contiguous with diffusion barrier 49, working electrode 22, and counter electrode 24 may include the boundaries formed by kerfs 51, 53, and 55. Boundaries non-contiguous with diffusion barrier 49 may include the boundaries between counter electrode conductive region 42 and fill-detect cathode conductive region 46, fill-detect cathode conductive region 46 and fill-detect anode conductive region 44, and fill-detect anode conductive region 44 and working electrode conductive region 40.
- dielectric spacer layer 64 can be applied to conductive layer 20, as illustrated in FIG. 5 .
- Spacer layer 64 can be applied to conductive layer 20 in a number of different ways.
- spacer layer 64 is provided as a sheet or web large enough and appropriately shaped to cover multiple test strip traces 80.
- the underside of spacer layer 64 can be coated with an adhesive to facilitate attachment to conductive layer 20.
- Portions of the upper surface of spacer layer 64 can also be coated with an adhesive in order to provide adhesive layer 78 in each of the test strips 10.
- Various slots can be cut, formed or punched out of spacer layer 64 to shape it before, during or after the application of spacer layer 64 to conductive layer 20.
- spacer layer 64 can have a pre-formed slot 98 for each test strip structure. Spacer layer 64 may then be positioned over conductive layer 20, as shown in FIG. 5 , and laminated to conductive layer 20. When spacer layer 64 is appropriately positioned on conductive layer 20, exposed electrode portions 54-62 are accessible through slot 98. Similarly, spacer layer 64 leaves contacts 32-38 and auto-on conductor 48 exposed after lamination.
- spacer layer 64 could be applied in other ways.
- spacer layer 64 can be injection molded onto base layer 18.
- Spacer layer 64 could also be built up on base layer 18 by screen-printing successive layers of a dielectric material to an appropriate thickness, e.g., about 0.005 inches.
- An exemplary dielectric material comprises a mixture of silicone and acrylic compounds, such as the " Membrane Switch Composition 5018" available from E.I. DuPont de Nemours & Co., Wilmington, Del . Other materials could be used, however.
- one or more kerfs may be formed following application of spacer layer 64 to base layer 18.
- spacer layer 64 may be applied to base layer 18 such that spacer layer 64 at least partially covers one or more electrical contacts 132, 134, 136, 138, and/or 148.
- one or more kerfs 101 can be formed by any suitable processing technique configured to remove sufficient material from spacer layer 64 and conductive layer 120, such as, for example, laser ablation using a high-energy or infrared laser.
- kerf 101 can be formed following application of a second conductive layer or semi-conductive layer to distal end of the test strip, as described by U.S. Patent Application No. 11/458,298 .
- Other processing techniques may be employed, including etching.
- Reagent layer 90 can then be applied to each test strip structure after forming spacer layer 64.
- reagent layer 90 is applied by micro-pipetting an aqueous composition onto exposed portion 54 of working electrode 22 and letting it dry to form reagent layer 90. It is also contemplated that reagent layer 90 may or may not contact diffusion barrier 49 and/or exposed portion 56 of counter electrode 24.
- An exemplary aqueous composition has a pH of about 6 and contains 2 weight % polyvinyl alcohol, 0.1 M potassium phosphate, 0.05 weight % Triton X-100, 0.15 M ruthenium hexamine, 0.7% hydroxyethylcellulose (such as NATROSOL®), and about 2500 units of glucose oxidase per mL.
- other methods such as screen-printing, can be used to apply the composition used to form reagent layer 90.
- reagent layer 90 can be applied before or concurrently with application of spacer layer 64.
- Cover 72 can then be attached to space layer 64, where cover 72 is constructed to cover slot 52.
- Cover 72 can include adhesive layer 78 configured to adhere to spacer layer 64.
- individual test strips 10 may be separated from the laminated reel.
- the separation process may include stamping or "punching out" of individual test cards in a "singulation" process.
- the singulation process could include laser ablation, stamping, cutting, or etching.
- one or more cover holes can be formed in cover 72 to provide suitable venting of sample chamber 88.
- a cover hole could be formed by any suitable processing technique, such as, for example, laser ablation, stamping, cutting, or etching.
- the cover hole could be formed using a carbon dioxide laser or other type of laser operated at an appropriate energy.
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- Hematology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Electrochemistry (AREA)
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- Analytical Chemistry (AREA)
- Molecular Biology (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Investigating Or Analyzing Materials By The Use Of Electric Means (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
Applications Claiming Priority (3)
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US79077306P | 2006-04-11 | 2006-04-11 | |
US87845407P | 2007-01-04 | 2007-01-04 | |
PCT/US2007/066163 WO2007121121A2 (en) | 2006-04-11 | 2007-04-06 | Laminated biosensor and its manufacturing method |
Publications (2)
Publication Number | Publication Date |
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EP2008087A2 EP2008087A2 (en) | 2008-12-31 |
EP2008087B1 true EP2008087B1 (en) | 2020-06-03 |
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EP07760264.7A Active EP2008087B1 (en) | 2006-04-11 | 2007-04-06 | Laminated biosensor manufacturing method |
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US (2) | US8128981B2 (zh) |
EP (1) | EP2008087B1 (zh) |
JP (1) | JP5313876B2 (zh) |
AU (1) | AU2007238249A1 (zh) |
BR (2) | BRPI0709971B8 (zh) |
MX (1) | MX2008012866A (zh) |
NO (1) | NO20084714L (zh) |
TW (1) | TWI472315B (zh) |
WO (1) | WO2007121121A2 (zh) |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9012232B2 (en) | 2005-07-15 | 2015-04-21 | Nipro Diagnostics, Inc. | Diagnostic strip coding system and related methods of use |
US8999125B2 (en) | 2005-07-15 | 2015-04-07 | Nipro Diagnostics, Inc. | Embedded strip lot autocalibration |
US7955856B2 (en) | 2005-07-15 | 2011-06-07 | Nipro Diagnostics, Inc. | Method of making a diagnostic test strip having a coding system |
US20080020452A1 (en) * | 2006-07-18 | 2008-01-24 | Natasha Popovich | Diagnostic strip coding system with conductive layers |
US20130228266A1 (en) * | 2010-12-10 | 2013-09-05 | Wen-Pin Hsieh | Manufacturing method of a test strip |
WO2013073073A1 (ja) * | 2011-11-18 | 2013-05-23 | 株式会社村田製作所 | バイオセンサおよびバイオセンサの製造方法 |
US9523653B2 (en) | 2013-05-09 | 2016-12-20 | Changsha Sinocare Inc. | Disposable test sensor with improved sampling entrance |
US9518951B2 (en) | 2013-12-06 | 2016-12-13 | Changsha Sinocare Inc. | Disposable test sensor with improved sampling entrance |
US9897566B2 (en) | 2014-01-13 | 2018-02-20 | Changsha Sinocare Inc. | Disposable test sensor |
US9939401B2 (en) | 2014-02-20 | 2018-04-10 | Changsha Sinocare Inc. | Test sensor with multiple sampling routes |
US9911013B2 (en) * | 2016-03-11 | 2018-03-06 | Trividia Health, Inc. | Systems and methods for correction of on-strip coding |
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EP1195441A1 (en) * | 2000-10-06 | 2002-04-10 | Roche Diagnostics GmbH | Biosensor |
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WO2005066616A2 (en) * | 2003-06-20 | 2005-07-21 | Roche Diagnostics Gmbh | Biosensor and method of making |
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US6103033A (en) * | 1998-03-04 | 2000-08-15 | Therasense, Inc. | Process for producing an electrochemical biosensor |
US6591125B1 (en) * | 2000-06-27 | 2003-07-08 | Therasense, Inc. | Small volume in vitro analyte sensor with diffusible or non-leachable redox mediator |
US6287451B1 (en) * | 1999-06-02 | 2001-09-11 | Handani Winarta | Disposable sensor and method of making |
US7276146B2 (en) * | 2001-11-16 | 2007-10-02 | Roche Diagnostics Operations, Inc. | Electrodes, methods, apparatuses comprising micro-electrode arrays |
CN1220053C (zh) * | 1999-11-15 | 2005-09-21 | 松下电器产业株式会社 | 生物传感器、定量装置及定量方法 |
US6492242B1 (en) * | 2000-07-03 | 2002-12-10 | Chartered Semiconductor Manufacturing Ltd. | Method of forming of high K metallic dielectric layer |
JP4120400B2 (ja) * | 2001-04-16 | 2008-07-16 | 松下電器産業株式会社 | バイオセンサ |
EP1642126A1 (en) * | 2003-06-20 | 2006-04-05 | Roche Diagnostics GmbH | System and method for coding information on a biosensor test strip |
-
2007
- 2007-04-06 WO PCT/US2007/066163 patent/WO2007121121A2/en active Application Filing
- 2007-04-06 AU AU2007238249A patent/AU2007238249A1/en not_active Abandoned
- 2007-04-06 EP EP07760264.7A patent/EP2008087B1/en active Active
- 2007-04-06 BR BRPI0709971A patent/BRPI0709971B8/pt active IP Right Grant
- 2007-04-06 BR BR122018005191A patent/BR122018005191B8/pt active IP Right Grant
- 2007-04-06 MX MX2008012866A patent/MX2008012866A/es active IP Right Grant
- 2007-04-06 JP JP2009505551A patent/JP5313876B2/ja active Active
- 2007-04-10 TW TW96112497A patent/TWI472315B/zh active
- 2007-04-10 US US11/783,568 patent/US8128981B2/en active Active
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2008
- 2008-11-07 NO NO20084714A patent/NO20084714L/no unknown
-
2012
- 2012-01-26 US US13/358,948 patent/US20120122198A1/en not_active Abandoned
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WO2001025775A1 (en) * | 1999-10-04 | 2001-04-12 | Roche Diagnostics Corporation | Patterned laminates and electrodes with laser defined features |
EP1195441A1 (en) * | 2000-10-06 | 2002-04-10 | Roche Diagnostics GmbH | Biosensor |
EP1302545A2 (en) * | 2001-10-09 | 2003-04-16 | Roche Diagnostics GmbH | Enzyme Biosensor |
US20030116447A1 (en) * | 2001-11-16 | 2003-06-26 | Surridge Nigel A. | Electrodes, methods, apparatuses comprising micro-electrode arrays |
US20040182703A1 (en) * | 2002-04-25 | 2004-09-23 | Home Diagnostics, Inc. | Systems and methods for blood glucose sensing |
US20050019953A1 (en) * | 2003-06-20 | 2005-01-27 | Henning Groll | System and method for coding information on a biosensor test strip |
WO2005066616A2 (en) * | 2003-06-20 | 2005-07-21 | Roche Diagnostics Gmbh | Biosensor and method of making |
Also Published As
Publication number | Publication date |
---|---|
BR122018005191B1 (pt) | 2018-07-03 |
BRPI0709971A2 (pt) | 2011-08-02 |
US8128981B2 (en) | 2012-03-06 |
TWI472315B (zh) | 2015-02-11 |
BR122018005191B8 (pt) | 2021-07-27 |
US20070286772A1 (en) | 2007-12-13 |
TW200803795A (en) | 2008-01-16 |
EP2008087A2 (en) | 2008-12-31 |
JP2009533686A (ja) | 2009-09-17 |
BRPI0709971B1 (pt) | 2018-06-19 |
WO2007121121A3 (en) | 2008-02-21 |
BRPI0709971B8 (pt) | 2021-07-27 |
US20120122198A1 (en) | 2012-05-17 |
MX2008012866A (es) | 2008-10-14 |
NO20084714L (no) | 2009-01-06 |
AU2007238249A1 (en) | 2007-10-25 |
JP5313876B2 (ja) | 2013-10-09 |
WO2007121121A2 (en) | 2007-10-25 |
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